Dosing & Uses
Dosage Forms & Strengths
tablet
- 400mg
- 800mg
Musculoskeletal Pain
Indicated for acute, painful musculoskeletal conditions
800 mg PO q6-8hr
Dosage Modifications
Renal impairment
- Mild to moderate impairment: Use caution
- Severe impairment: Contraindicated
Hepatic impairment
- Mild to moderate impairment: Use caution
- Severe impairment: Contraindicated
Systemic Sclerosis (Orphan)
Uvadex
In conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Cardiac Allograft Rejection (Orphan)
Uvadex
Prevention of acute rejection of cardiac allografts
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Dosage Forms and Strengths
tablet
- 400mg
- 800mg
Musculoskeletal Pain
<12 years: Safety and efficacy not established
≥12 years: 800 mg PO q6-8hr
Systemic Sclerosis (Orphan)
Uvadex
In conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Cardiac Allograft Rejection (Orphan)
Uvadex
Prevention of acute rejection of cardiac allografts
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Drug-induced gastrointestinal disturbance
Nausea
Vomiting
Dizziness
Headache
Somnolence
Nervousness
Hemolytic anemia (rare)
Leukopenia (rare)
Jaundice (rare)
Immune hypersensitivity reaction (rare)
Warnings
Contraindications
Hypersensitivity
History of drug-induced hemolytic anemia
Significant renal/hepatic impairment
Cautions
CNS depression may occur
Sedative effects may be potentiated when used with other sedatives
Medication is poorly tolerated by the elderly
Bioavailability may increase in female patients
Use caution in renal and hepatic impairment
Safety and efficacy not established in children <12 years
May impair physical or mental abilities; caution patient against operating heavy machinery or performing taks requiring mental alertness
Cases of serotonin syndrome, a potentially life-threatening condition, reported during concomitant use of serotonergic drugs with dose within recommended range and with a single agent taken at doses higher than recommended dose; onset of symptoms generally occurs within several hours to a few days, but may occur later than that; discontinue therapy if serotonin syndrome suspected
Sedative effects of and other CNS depressants (eg, alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive; exercise caution with patients who take more than one of CNS depressants simultaneously; follow patients closely for signs and symptoms of respiratory depression and sedation
Pregnancy & Lactation
Pregnancy category: C
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
General CNS depression; no direct effect on skeletal muscle; may disrupt the spasm-pain-spasm cycle; does not havae direct effect on skeletal muscle
Absorption
Onset: Within 1 hr
Duration: 4-6 hr
Peak plasma time: 3 hr
Peak plasma concentration: 296 mcg/mL
Distribution
Vd: 800 L
Metabolism
Liver
Metabolites: Unidentified
Elimination
Half-life elimination: 4-14 hr
Excretion: Urine
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
